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Mylan product recalls (2015-03-13)
- Starting date:
- March 13, 2015
- Posting date:
- March 24, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52647
Recalled Products
- CISplatin Injection, Mylan Std.
- Gemcitabine for Injection, USP 1 g/vial
- Gemcitabine for Injection, USP 2 g/vial
- Topotecan Hydrochloride for Injection
Reason
This lot is recalled due to a potential of foreign matter in the product.
Depth of distribution
Wholesalers, pharmacies, hospitals, clinics
Affected products
A. CISplatin Injection, Mylan Std.
DIN, NPN, DIN-HIM
DIN 02396890
Dosage form
Solution
Strength
Cisplatin 1 mg / mL
Lot or serial number
7800993
Companies
- Recalling Firm
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
- Marketing Authorization Holder
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
B. Gemcitabine for Injection, USP 1 g/vial
DIN, NPN, DIN-HIM
DIN 02407302
Dosage form
Powder for Solution
Strength
Gemcitabine (Gemcitabine Hydrochloride) 1 g/vial
Lot or serial number
7801243
Companies
- Recalling Firm
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
- Marketing Authorization Holder
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
C. Gemcitabine for Injection, USP 2 g/vial
DIN, NPN, DIN-HIM
DIN 02407310
Dosage form
Powder for Solution
Strength
Gemcitabine (Gemcitabine Hydrochloride) 2 g/vial
Lot or serial number
7801253
Companies
- Recalling Firm
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
- Marketing Authorization Holder
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
D. Topotecan Hydrochloride for Injection
DIN, NPN, DIN-HIM
DIN 02396564
Dosage form
Powder for Solution
Strength
Topotecan (Topotecan Hydrochloride) 4 mg/vial
Lot or serial number
7800978, 7800981
Companies
- Recalling Firm
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA
- Marketing Authorization Holder
-
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke
M8Z 2S6
Ontario
CANADA